PrevalenceNCT04682938
The Prevalence and Characteristics of Adrenal Incidentaloma
An observational study of Prevalence and Adrenal Incidentaloma, run by Chongqing Medical University at 1 site in China.
Trial summary
To investige the prevalence, characteristics and prognosis of adrenal incidentalomas in Chinese adults. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevalence, Adrenal Incidentaloma
- How many people
- 25,356 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2020to 30 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chinese community adults
Who may be able to join
- ·On weekdays, the first 100 individuals, aged 18 to 78 years, taking health checkup in the Community Health Examination Center were invited to take part in the study.
Who cannot join
- with known adrenal diseases;
- with continuous steroids or drug treatment that might influence cortisol secretion ordexamethasone metabolism and could not be stopped
- refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Chongqing Medical University, Chongqing, China
Chongqing, Chongqing Municipality, 400016
About this study
Official title: The Prevalence and Characteristics of Adrenal Incidentaloma: A Prospective Study
To investige the prevalence, characteristics and prognosis of adrenal incidentalomas in Chinese adults.
Read the detailed description
With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. Most AI are benign and do not have the function of autonomic hormone secretion, but about 20% of them have function and can secrete adrenal hormone autonomously. Studies based on biopsy reports show that the prevalence of AI is about 2%, and the prevalence of AI detected by CT scan is 1% - 4.5%. However, most of these studies are retrospective, and there may be selection bias and other confounding factors. There is no large sample prospective study on the prevalence of AI in the general population. The purpose of this study is to prospectively include patients with adrenal incidentaloma in community physical examination population, and evaluate their function and prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenal incidentaloma in the future.
- Conditions
- Prevalence, Adrenal Incidentaloma
- Keywords
- Prevalence, characteristics, adrenal incidentaloma
- Medical subject headings
- Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adrenal incidentalomas in Chinese community adults | On weekdays, the first 100 individuals, aged 18 to 78 years, taking health checkup in the Community Health Examination Center were invited to take part in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and Characteristics of Adrenal Incidentaloma
To investigate the prevalence and characteristics of Adrenal Incidentaloma in general population in China
Measured: 1 years
Secondary outcomes (1)
Steroid hormones in the function of Adrenal Incidentaloma
prospectively evaluate potential predictive role of combined detection of multiple steroid hormones in the function of Adrenal Incidentaloma
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start20 Nov 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PrevalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, Chongqing Medical University
- Investigators
- Li Qifu, PhD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682938
- Sponsor's protocol ID
- AI-China2020
- Status last verified
- Aug 2022
- First submitted
- 21 Dec 2020
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ichijo T, Ueshiba H, Nawata H, Yanase T. A nationwide survey of adrenal incidentalomas in Japan: the first report of clinical and epidemiological features. Endocr J. 2020 Feb 28;67(2):141-152. doi: 10.1507/endocrj.EJ18-0486. Epub 2019 Nov 7.
PubMed 31694993Lee JM, Kim MK, Ko SH, Koh JM, Kim BY, Kim SW, Kim SK, Kim HJ, Ryu OH, Park J, Lim JS, Kim SY, Shong YK, Yoo SJ; Korean Endocrine Society, Committee for Clinical Practice Guidelines. Clinical Guidelines for the Management of Adrenal Incidentaloma. Endocrinol Metab (Seoul). 2017 Jun;32(2):200-218. doi: 10.3803/EnM.2017.32.2.200.
PubMed 28685511Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.
PubMed 27390021Li J, Xiong Y, Li J, Ma L, Song Y, Luo R, Luo Z, Mao Y, Shen H, Hu J, Yang S, Li Q, Jing Y; Chongqing Primary Aldosteronism Study (CONPASS) Group. Characteristics and etiological profile of bilateral adrenal nodules: A Post-hoc analysis. Endocrine. 2026 Mar 11;91(1):112. doi: 10.1007/s12020-026-04576-w.
PubMed 41811595Jing Y, Hu J, Luo R, Mao Y, Luo Z, Zhang M, Yang J, Song Y, Feng Z, Wang Z, Cheng Q, Ma L, Yang Y, Zhong L, Du Z, Wang Y, Luo T, He W, Sun Y, Lv F, Li Q, Yang S. Prevalence and Characteristics of Adrenal Tumors in an Unselected Screening Population : A Cross-Sectional Study. Ann Intern Med. 2022 Oct;175(10):1383-1391. doi: 10.7326/M22-1619. Epub 2022 Sep 13.
PubMed 36095315
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence and Characteristics of Adrenal Incidentaloma: A Prospective Study
- ClinicalTrials.gov ID
- NCT04682938
- Acronym / sponsor ID
- AI-China2020
- Conditions
- Prevalence, Adrenal Incidentaloma
- Keywords
- Prevalence, characteristics, adrenal incidentaloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,356 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investige the prevalence, characteristics and prognosis of adrenal incidentalomas in Chinese adults.
Detailed description
With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. Most AI are benign and do not have the function of autonomic hormone secretion, but about 20% of them have function and can secrete adrenal hormone autonomously. Studies based on biopsy reports show that the prevalence of AI is about 2%, and the prevalence of AI detected by CT scan is 1% - 4.5%. However, most of these studies are retrospective, and there may be selection bias and other confounding factors. There is no large sample prospective study on the prevalence of AI in the general population. The purpose of this study is to prospectively include patients with adrenal incidentaloma in community physical examination population, and evaluate their function and prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenal incidentaloma in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adrenal incidentalomas in Chinese community adults | – | –On weekdays, the first 100 individuals, aged 18 to 78 years, taking health checkup in the Community Health Examination Center were invited to take part in the study. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese community adults
Key inclusion criteria (1 listed)
- ·On weekdays, the first 100 individuals, aged 18 to 78 years, taking health checkup in the Community Health Examination Center were invited to take part in the study.
Key exclusion criteria (3 listed)
- with known adrenal diseases;
- with continuous steroids or drug treatment that might influence cortisol secretion ordexamethasone metabolism and could not be stopped
- refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and Characteristics of Adrenal Incidentaloma
Time frame: 1 years
To investigate the prevalence and characteristics of Adrenal Incidentaloma in general population in China
1 secondary outcome
Steroid hormones in the function of Adrenal Incidentaloma
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- Results publication: PubMed 31694993Ichijo T, Ueshiba H, Nawata H, Yanase T. A nationwide survey of adrenal incidentalomas in Japan: the first report of clinical and epidemiological features. Endocr J. 2020 Feb 28;67(2):141-152. doi: 10.1507/endocrj.EJ18-0486. Epub 2019 Nov 7.
- Results publication: PubMed 28685511Lee JM, Kim MK, Ko SH, Koh JM, Kim BY, Kim SW, Kim SK, Kim HJ, Ryu OH, Park J, Lim JS, Kim SY, Shong YK, Yoo SJ; Korean Endocrine Society, Committee for Clinical Practice Guidelines. Clinical Guidelines for the Management of Adrenal Incidentaloma. Endocrinol Metab (Seoul). 2017 Jun;32(2):200-218. doi: 10.3803/EnM.2017.32.2.200.
- Results publication: PubMed 27390021Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.
- Derived from this study: PubMed 41811595Li J, Xiong Y, Li J, Ma L, Song Y, Luo R, Luo Z, Mao Y, Shen H, Hu J, Yang S, Li Q, Jing Y; Chongqing Primary Aldosteronism Study (CONPASS) Group. Characteristics and etiological profile of bilateral adrenal nodules: A Post-hoc analysis. Endocrine. 2026 Mar 11;91(1):112. doi: 10.1007/s12020-026-04576-w.
- Derived from this study: PubMed 36095315Jing Y, Hu J, Luo R, Mao Y, Luo Z, Zhang M, Yang J, Song Y, Feng Z, Wang Z, Cheng Q, Ma L, Yang Y, Zhong L, Du Z, Wang Y, Luo T, He W, Sun Y, Lv F, Li Q, Yang S. Prevalence and Characteristics of Adrenal Tumors in an Unselected Screening Population : A Cross-Sectional Study. Ann Intern Med. 2022 Oct;175(10):1383-1391. doi: 10.7326/M22-1619. Epub 2022 Sep 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Qifu, PhD principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevalence and Adrenal Incidentaloma, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and Characteristics of Adrenal Incidentaloma (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04682938, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.